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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantIcad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062
PMA NumberP010034
Supplement NumberS004
Date Received05/30/2003
Decision Date10/31/2003
Withdrawal Date04/08/2011
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THREE USER PREFERRED THRESHOLD SETTINGS FOR THE PERFORMANCE OF SECOND LOOK ANALOG 6.0 CAD SYSTEM, UPDATED CAD ALGORIGHMS TO INCREASE SENSITIVITY, AND NEW UPDATED COMMERCIAL DATABASE DRIVER FOR IMPROVED SPEED AND RELIABILITY FOR THE SYSTEM.
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